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Five-Year Survival Results of Subcutaneous Low-Dose Immunotherapy with Interleukin-2 Alone in Metastatic Renal Cell Cancer Patients

2000; Karger Publishers; Volume: 64; Issue: 1 Linguagem: Inglês

10.1159/000030473

1423-0399

Veronica Bordin, Luisa Giani, Sofia Meregalli, Roberta Bukovec, Massimo Vaghi, Mario Mandalà, Franco Paolorossi, A. Ardizzoia, G. Tancini, S. Barni, Franco Frigerio, Luca Fumagalli, Arrigo Bordoni, Gianni Valsuani, Greta Di Felice, Paolo Lissoni,

Bladder and Urothelial Cancer Treatments

After the discovery of its essential role in anticancer immunity, IL-2 cancer immunotherapy has shown that comparable results may be obtained with different schedules, including intravenous high-dose IL-2 as a bolus or as a 24-hour intravenous infusion or prolonged subcutaneous injection of low-dose IL-2 with or without IFN-α. This study shows the long-term results obtained in 92 metastatic renal cell cancer (RCC) patients with low-dose subcutaneous IL-2, which was given at 3 million IU twice/day for 5 days/week for 6 consecutive weeks. In nonprogressing patients, a second cycle was planned after a 21-day rest period, followed by maintenance therapy consisting of 5 days of treatment every month until disease progression. Complete response (CR) was achieved in only 2/92 (2%) patients, and partial response (PR) was observed in 19 patients (21%). Therefore, the response rate (CR + PR) was 21/92 (23%), with a median duration of response of 25 months. Stable disease (SD) occurred in 37 patients (40%), whereas the other 34 (37%) had a progressive disease (PD). The response rate was significantly higher in patients with a disease-free interval of >1 year than in those with a lower interval, in patients with a high performance status (PS) than in those with a low PS, and in patients with sites of disease other than the liver. A 5-year survival was obtained in 9/92 (9%) patients, and the percent of survival was significantly higher in patients with a response or SD than in those with PD. The treatment was well tolerated in all patients. This study confirms that low-dose subcutaneous IL-2 alone in an effective and well tolerated therapy of metastatic RCC, with results comparable to those described with more aggressive and toxic IL-2 schedules.